Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: July 8, 2002
Last updated: August 17, 2010
Last verified: August 2007

July 8, 2002
August 17, 2010
September 2002
April 2008   (final data collection date for primary outcome measure)
Objective tumor response rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00040859 on ClinicalTrials.gov Archive Site
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
Not Provided
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Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.



  • Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine.


  • Determine the time to progression and overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR.

Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy).

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A maximum of 44 patients will be accrued for this study within 26 months.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: capecitabine
  • Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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Not Provided
April 2008   (final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists

    • Unresectable disease
    • Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach
  • Measurable disease
  • No known CNS metastases



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 3 times ULN
  • Alkaline phosphatase no greater than 2 times ULN


  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 60 mL/min


  • No New York Heart Association class III or IV heart disease


  • Able to swallow capecitabine
  • No unresolved gastrointestinal bleeding
  • No uncontrolled infection
  • No chronic debilitating disease
  • No peripheral neuropathy grade 2 or greater
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior immunotherapy or biological therapy for recurrent or metastatic disease
  • No concurrent biologic agents


  • No prior chemotherapy for recurrent or metastatic disease
  • Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • See Chemotherapy
  • No prior radiotherapy for recurrent or metastatic disease
  • No prior radiotherapy to more than 25% of the bone marrow
  • Prior adjuvant or neoadjuvant radiotherapy allowed
  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • More than 4 weeks since prior abdominal exploration with surgical resection
  • More than 3 weeks since prior abdominal exploration without surgical resection


  • No concurrent oral cryotherapy during oxaliplatin administration
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000069413, NCCTG-N0149
Not Provided
Not Provided
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic
National Cancer Institute (NCI)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP